Internet-delivered [CBT] for chronic fatigue among adolescents with a chronic medical condition, 2023, Nijhof, van de Putte, Knoop et al

[Sly Saint]

Internet-delivered cognitive behavioural therapy for chronic fatigue among adolescents with a chronic medical condition: a single case study

Abstract
Background:
Severe fatigue is a prominent symptom among adolescents with a chronic medical condition, with major impact on their well-being and daily functioning. Internet-based cognitive behavioural therapy (I-CBT) is a promising treatment for severe fatigue among adolescents with a chronic medical condition, but its effectiveness has not been studied.

Aims:
We developed an I-CBT intervention for disabling fatigue in a chronic medical condition and tested its feasibility and effectiveness in an adolescent with an immune dysregulation disorder (IDD), namely juvenile idiopathic arthritis (JIA).

Method:
The application of I-CBT is illustrated through a clinical case study of a 15-year-old girl with JIA and chronic severe fatigue. An A-B single case experimental design was used with randomization of the waiting period prior to start of the intervention. Outcomes were weekly measures of fatigue severity, physical functioning, school absence and pain severity.

Results:
Fatigue severity significantly decreased following I-CBT. Improvements were observed towards increased school attendance and improved physical functioning following the intervention, but these effects were too small to become significant.

Conclusions:
The study provides preliminary support for the feasibility and effectiveness of the application of I-CBT for severe fatigue in adolescents with a long-term medical condition.

https://www.cambridge.org/core/jour...e-case-study/D451919571B112EE255B6DC00CC78E73

seriously?

 

[Hoopoe]

This seems to show once again that cognitive factors have don't have a causal role in disability.

Whether the fatigue has really improved or not is also unclear.

 

[rvallee]

By definition, if it's too small to be significant, it's not effective. Good grief these people have been selling this as a complete cure for decades onto millions of people and here they are trying to make something out of single anecdotes that don't even mean anything.

They tried selling a useless product and now they have so much supply for it and there's no one in a position to make a difference with the courage to stop this madness.

 

[Hutan]

It's bizarre, isn't it. Large surveys with patients reporting that CBT doesn't treat fatigue; large numbers of patient charities reporting that CBT doesn't treat fatigue - all these are worth nothing. But the case study of one person who reports reduced fatigue but shows no significant improvement in objective measures warrants a whole paper and the conclusion that this study provides preliminary support for its effectiveness and feasibility.

The application of I-CBT is illustrated through a clinical case study of a 15-year-old girl with JIA and chronic severe fatigue. An A-B single case experimental design was used with randomization of the waiting period prior to start of the intervention.

I'm mildly interested to know how you randomise the waiting period in an experimental design when you have one participant and the treatment is unblinded. But not enough to be bothered to read the paper.

 

[Hutan]

So, I'm procrastinating, and finding out the utility of a randomised waiting period in an unblinded trial with only one participant proved too interesting

Re ME/CFS:

As observed in ME/CFS, beliefs and behavioural factors are involved in the perpetuation of fatigue in IDD. Likewise, addressing these factors is the starting point for appropriate therapeutic interventions.

A single case experimental design (SCED) was conducted, including a randomized time interval prior to the start of the intervention and using time series to evaluate the feasibility and effectiveness following I-CBT. This single case study was part of a larger study with nine patients with an IDD. In this paper, one case is described in depth to enable a thorough introduction of this novel treatment.

So, there were 9 participants, but for whatever reason, they aren't going to tell us about that. Hmm. Perhaps some risk of bias?
Novel treatment? Somehow, it's both a novel treatment and an extension of FITNET (see below).
Randomising the number of weeks of baseline analysis makes no sense when you are considering school absences. Schools have patterns of holidays that need to be considered in study designs. In this case, there was 8 weeks of baseline, with actigraphy only measured for 2 weeks. There was 26 weeks of treatment and 16 weeks followup assessment.

Seems that it's standard practice not to assess actigraphy after treatment:

Actigraphy, the actigraphy is deliberately not assessed at T1. Various treatment studies of chronic fatigue have shown that an increase in physical activity does not mediate the response to CBT (Poort et al., 2021; Wiborg et al., 2010). Actigraphy helps to determine which treatment protocol a patient has to follow (for low active or relative active patients) and is therefore only used at baseline. Sarah followed the treatment protocol for low active patients

Predisposing factors: Sarah has a greater chance of developing chronic fatigue because of her gender. In addition, there are negative life events (divorce of parents and no contact with her father), premorbid psychopathology (mood disorder) and personality traits, especially perfectionism, that may made her more prone to develop fatigue.

I hate to think of the messing about these researchers did with this young person's sense of herself.

Based on these measurements the following perpetuating factors were identified: a low activity pattern, disturbed sleep-wake rhythm, and a tendency to catastrophize fatigue and JIA. Example of the latter are ‘I usually think of everything that could go wrong because of fatigue’ or ‘JIA makes me feel useless

This is an extension of FITNET

FITNET-plus builds on FITNET: an established eHealth CBT protocol for ME/CFS in adolescents (Albers et al., Reference Albers, Nijhof, Berkelbach van der Sprenkel, Van de Putte, Nijhof and Knoop2021) and is enriched with elements of evidence-based CBT protocols for fatigued adults with a chronic medical condition

In case of a disease flare Sarah contacted her rheumatologist and the I-CBT paused until disease remission was achieved (commensurate with the advice of our Ethical Review Board).

Because Sarah was hospitalized for severe constipation in the follow-up period, the weekly follow-up measurements were (in accordance with the study protocol) postponed to disease remission.

Yep, you read that right. The one participant of this case study was hospitalised during the followup period. The 'during treatment (17/26 weeks)' and followup measurements only occurred when the young person was feeling ok.

I can't work out what is happening in the charts regarding the weekly measurements, there are enormous gaps in the data, and different numbers of weekly reporting for different measures. e.g. school absence only seems to go to week 19 while fatigue goes to about week 25.

So, they just picked one person out of 9 participants, and they just picked the periods when she felt better to make the measurements of improvement. And, even then, they couldn't show any objective improvements. This "study" is one of the worst papers I have seen in terms of bias.

@dave30th - you might be interested in this latest incarnation of FITNET. It looks as though comments can be submitted to the journal.

 

[Sean]

This "study" is one of the worst papers I have seen in terms of bias.

It is truly shocking stuff, isn't it.

Particularly in 2023, after all that has been exposed about this garbage, they still just assert their claims and assumptions as proven.

How are we supposed to counter this kind of endless blatant bias and fraud and cruelty?

 

[bobbler]

Internet-delivered cognitive behavioural therapy for chronic fatigue among adolescents with a chronic medical condition: a single case study

Abstract
Background:
Severe fatigue is a prominent symptom among adolescents with a chronic medical condition, with major impact on their well-being and daily functioning. Internet-based cognitive behavioural therapy (I-CBT) is a promising treatment for severe fatigue among adolescents with a chronic medical condition, but its effectiveness has not been studied.

Aims:
We developed an I-CBT intervention for disabling fatigue in a chronic medical condition and tested its feasibility and effectiveness in an adolescent with an immune dysregulation disorder (IDD), namely juvenile idiopathic arthritis (JIA).

Method:
The application of I-CBT is illustrated through a clinical case study of a 15-year-old girl with JIA and chronic severe fatigue. An A-B single case experimental design was used with randomization of the waiting period prior to start of the intervention. Outcomes were weekly measures of fatigue severity, physical functioning, school absence and pain severity.

Results:
Fatigue severity significantly decreased following I-CBT. Improvements were observed towards increased school attendance and improved physical functioning following the intervention, but these effects were too small to become significant.

Conclusions:
The study provides preliminary support for the feasibility and effectiveness of the application of I-CBT for severe fatigue in adolescents with a long-term medical condition.

https://www.cambridge.org/core/jour...e-case-study/D451919571B112EE255B6DC00CC78E73

seriously?

Improvements were observed towards increased school attendance and improved physical functioning following the intervention, but these effects were too small to become significant.

Publications need to sort themselves out - it is a standing joke now. When did people get away with writing "trust me guv, I definitely think they seemed much better after they did my treatment that I'm asking for funding on" in a 'scientific' research publication? Are they not embarrassed to be printing that? Is that what BPS call their 'evidence'? their own personal writing of a one-liner like that then claiming it is 'peer-reviewed' so is 'evidence'?

People should surely have to write the phrase 'hypothesis rejected', 'not proven', 'was not significant' ie not proven in the Results: -- bit
and then should have to have Conclusion(s): --- based on those basic tenets of hypothesis was either rejected or proven being 'what the results must be' and actually follow-on from them.

It is a switch-and-bait plain and simple if your results eventually admit 'not significant' then conclusion claims 'support', 'feasilbility' and 'effectiveness' ie the opposite - or am I missing something?

 

[bobbler]

So, I'm procrastinating, and finding out the utility of a randomised waiting period in an unblinded trial with only one participant proved too interesting

Re ME/CFS:



So, there were 9 participants, but for whatever reason, they aren't going to tell us about that. Hmm. Perhaps some risk of bias?
Novel treatment? Somehow, it's both a novel treatment and an extension of FITNET (see below).
Randomising the number of weeks of baseline analysis makes no sense when you are considering school absences. Schools have patterns of holidays that need to be considered in study designs. In this case, there was 8 weeks of baseline, with actigraphy only measured for 2 weeks. There was 26 weeks of treatment and 16 weeks followup assessment.

Seems that it's standard practice not to assess actigraphy after treatment:




I hate to think of the messing about these researchers did with this young person's sense of herself.


This is an extension of FITNET





Yep, you read that right. The one participant of this case study was hospitalised during the followup period. The 'during treatment (17/26 weeks)' and followup measurements only occurred when the young person was feeling ok.

I can't work out what is happening in the charts regarding the weekly measurements, there are enormous gaps in the data, and different numbers of weekly reporting for different measures. e.g. school absence only seems to go to week 19 while fatigue goes to about week 25.

So, they just picked one person out of 9 participants, and they just picked the periods when she felt better to make the measurements of improvement. And, even then, they couldn't show any objective improvements. This "study" is one of the worst papers I have seen in terms of bias.

@dave30th - you might be interested in this latest incarnation of FITNET. It looks as though comments can be submitted to the journal.

Just in case anyone who hasn't seen other threads illuminating why Knoop etc don't like to use actigraphy I'll add it in after his claimed 'explanation'

Seems that it's standard practice not to assess actigraphy after treatment:

Actigraphy, the actigraphy is deliberately not assessed at T1. Various treatment studies of chronic fatigue have shown that an increase in physical activity does not mediate the response to CBT (Poort et al., 2021; Wiborg et al., 2010). Actigraphy helps to determine which treatment protocol a patient has to follow (for low active or relative active patients) and is therefore only used at baseline. Sarah followed the treatment protocol for low active patients

From the following paper in 2013, which included Knoop: https://www.s4me.info/threads/the-p...n-fatigue-2013-knoop-et-al.24643/#post-406586

Yes, that is quite a result. So, the 'fast responders' thought they were doing increasing amounts of activity after treatment, but actually they were doing pretty much the same amount of activity throughout.

One quote on this result from the actual 2013 paper is:

Lower pre-treatment objective activity predicted lower fatigue at the first interim measurement. This finding is difficult to explain. Levels of objective activity during treatment were not related to subsequent levels of fatigue at other measurements. In the early phases of treatment, even patients who remain severely fatigued after treatment increase their level of physical activity (see Fig. 3). So an increase in physical activity per se does not seem sufficient to reduce fatigue. An increase in perceived activity, however, does seem important. Besides, the increase in physical activity was frequently mentioned by patients as being helpful.

I bolded that last line because it needs to be caveated with mentioning the method in the paper included not telling people their actimetry, so the 'increase in physical activity' being mentioned by patients is likely based on their perceived levels of activity which are 'out of kilter' with objective activity as per the graph above for anyone who responded to 'the treatment'.

It shows how the 'reframing mindset' of this type of CBT can sadly warp into reframing reality and results.

I can't help but wonder when is someone going to call out 'the 'reframing/reframers(?)' School' and their type of 'reframing' by other terms that you could use for it?

 

[bobbler]

So, I'm procrastinating, and finding out the utility of a randomised waiting period in an unblinded trial with only one participant proved too interesting

Re ME/CFS:



So, there were 9 participants, but for whatever reason, they aren't going to tell us about that. Hmm. Perhaps some risk of bias?
Novel treatment? Somehow, it's both a novel treatment and an extension of FITNET (see below).
Randomising the number of weeks of baseline analysis makes no sense when you are considering school absences. Schools have patterns of holidays that need to be considered in study designs. In this case, there was 8 weeks of baseline, with actigraphy only measured for 2 weeks. There was 26 weeks of treatment and 16 weeks followup assessment.

Seems that it's standard practice not to assess actigraphy after treatment:




I hate to think of the messing about these researchers did with this young person's sense of herself.


This is an extension of FITNET





Yep, you read that right. The one participant of this case study was hospitalised during the followup period. The 'during treatment (17/26 weeks)' and followup measurements only occurred when the young person was feeling ok.

I can't work out what is happening in the charts regarding the weekly measurements, there are enormous gaps in the data, and different numbers of weekly reporting for different measures. e.g. school absence only seems to go to week 19 while fatigue goes to about week 25.

So, they just picked one person out of 9 participants, and they just picked the periods when she felt better to make the measurements of improvement. And, even then, they couldn't show any objective improvements. This "study" is one of the worst papers I have seen in terms of bias.

@dave30th - you might be interested in this latest incarnation of FITNET. It looks as though comments can be submitted to the journal.

In case of a disease flare Sarah contacted her rheumatologist and the I-CBT paused until disease remission was achieved (commensurate with the advice of our Ethical Review Board).

Because Sarah was hospitalized for severe constipation in the follow-up period, the weekly follow-up measurements were (in accordance with the study protocol) postponed to disease remission.

Yep, you read that right. The one participant of this case study was hospitalised during the followup period. The 'during treatment (17/26 weeks)' and followup measurements only occurred when the young person was feeling ok.

I can't work out what is happening in the charts regarding the weekly measurements, there are enormous gaps in the data, and different numbers of weekly reporting for different measures. e.g. school absence only seems to go to week 19 while fatigue goes to about week 25.

So, they just picked one person out of 9 participants, and they just picked the periods when she felt better to make the measurements of improvement. And, even then, they couldn't show any objective improvements. This "study" is one of the worst papers I have seen in terms of bias.

This is astounding!

First I note my relief that (my bolding) an Ethical Review Board steps in to stop her I-CBT when she 'has a flare' - otherwise known as getting worse if you don't play into the misleading terms 'relapse/flare' used by BPS for 'gets worse from normal level of illness that doesn't 'return to normal' (because it isn't a condition of 'flares')'

Secondly - yes to everything you say.

First she ended up getting worse enough the rheumatologist was consulted and the ethics board stopped 'i-CBT' and then she ended up in hospital, and they waited for that treatment and rest from their treatment before they then claimed 'how she was at that point' was their results

If this was based on one case study I hope they are selling it as what it is, something that from an 'objective measure' perspective had someone go into a deterioration that they had to stop 'i-cbt' to recover from, and then hospitalised

- how is that 'commensurate with' stating results as: "Improvements were observed towards increased school attendance and improved physical functioning following the intervention, but these effects were too small to become significant"???

 

[Sean]

Levels of objective activity during treatment were not related to subsequent levels of fatigue at other measurements. In the early phases of treatment, even patients who remain severely fatigued after treatment increase their level of physical activity (see Fig. 3). So an increase in physical activity per se does not seem sufficient to reduce fatigue. An increase in perceived activity, however, does seem important. Besides, the increase in physical activity was frequently mentioned by patients as being helpful.

FFS, if there is no correlation then there is no causation. Perceived or otherwise. That is not up for debate.

Once again [bolding mine]:

"in the later stages of treatment patients are encouraged to increase their activity (which must ultimately be the aim of any treatment)"

Wessely, David, Butler, & Chalder – 1990

And increase in activity is objectively measurable.

 

[Hutan]

Nice linking @bobbler.

Authors of this 2023 study
Linde N. Nijhof
Sanne L. Nijhof,
Elise M. van de Putte,
Jan Houtveen,
Joris M. van Montfrans and
Hans Knoop

Doing some linking of my own, I see that we have a tag for fitnet-plus, which links though to this trial registration from about five years ago.
[Just a registration] Paediatric immune dysregulation disorders - FITNET plus from Elise van de Putte ISRCTN12612526
I assume there is some connection; possibly it's even the same study.

In that thread Elise van de Putte (one of the authors of this study) is quoted as saying

Listening to patients is good, says pediatrician and professor Elise van de Putte. "Of course you have to take patients seriously. Of course you want to know what they think of their treatment and how they are treated. But should you also allow them to judge scientific evidence? "She does not think so. "You also do not ask anti-vaxxers to judge the evidence for the effectiveness of vaccinations. Science is not an 'opinion'. Research must meet strict criteria. "

I guess you'd be worried about patients judging your papers too if you kept producing work of this standard. I find it frightening that van de Putte is both a paediatrician and a professor. Edit - oh, and (from the linked thread) Chairman of a Research Ethics Committee.

"Research must meet strict criteria". Well, yes.

 

[Sean]

Research must meet strict criteria.

If only it would.

 

[bobbler]

Nice linking @bobbler.

Authors of this 2023 study
Linde N. Nijhof
Sanne L. Nijhof,
Elise M. van de Putte,
Jan Houtveen,
Joris M. van Montfrans and
Hans Knoop

Doing some linking of my own, I see that we have a tag for fitnet-plus, which links though to this trial registration from about five years ago.
[Just a registration] Paediatric immune dysregulation disorders - FITNET plus from Elise van de Putte ISRCTN12612526
I assume there is some connection; possibly it's even the same study.

In that thread Elise van de Putte (one of the authors of this study) is quoted as saying

I guess you'd be worried about patients judging your papers too if you kept producing work of this standard. I find it frightening that van de Putte is both a paediatrician and a professor. Edit - oh, and (from the linked thread) Chairman of a Research Ethics Committee.

"Research must meet strict criteria". Well, yes.

As an aside it has struck me just now that are there 2 areas/specialisms of medicine with more of a power-imbalance over patients/for patients word to be heard etc than psychiatry or pediatrics - and what that should really mean as far as additional protections to ensure a 'tendency not to hear or take seriously' doesn't lead to issues if it is happening even in the research stages etc.

Should there be even more safeguards re: objective measures being required and independence built in and guaranteed in administration of any subjective aspects and absolutely ensuring there can be no 'perception of threats possibly associated with 'incorrect answers', or not pushing onself to 'attend school even if extremely unwell'' etc.

It does feel like Ethics COmmittee is one place where this would come in, and it does feel like someone outside the sector and 'system' (as BPS ideology has been inbuilt through so many) - and why not parents and non-BPS scientists - are perhaps needed for objectivity, independence etc.

One thing that really concerns me is the lack of proper outcome measures with regards whether - one of the main points of school - short-term, medium and long-term children's actual education and health were benefitted one way or another.

It is bad enough imagining the impact of presenteeism being enforced at work due to financial constraints ending up with someone's condition getting permanently worse. But for a child, who might have recovered if they had enough time off, or benefitted from doing things a different way school-wise, is using 'school attendance' even actually either appropriate or separate from external influences (such as fines or being made to by other worries).

It seems a cyclical 'missing the point' when someone says 'school's important' because of their education and then it being used as a measure of apparent health colludes to 'encourage' someone to attend without anyone bothering to check it doesn't make their health worse and their educational attainment worse (and potentially their ability to attend school in future worse) than if they'd had homeschooling arrangements. And the 'being with friends' stuff I take with a pinch of salt too given if you feel terribly ill and it makes your health worse I'm unsure that can be a selling point over arrangements for schoolfriends to keep in touch in ways that doesn't overexert etc.

 

[Solstice]

Linde Nijhof is in the business of helping asthma-patients getting control over their asthma by improving their quality of life. Sanne Nijhof works for a peadiatric hospital with the purpose of developing web-based interventions.

The future goal of Sanne Nijhof is to make evidence based e-health platforms available to all children, treating their fatigue and pain and daily consequences associated with various somatic conditions.

https://www.umcutrecht.nl/en/research/researchers/nijhof-sanne-sl

Jan Oostveen is apparently big on SOLK, if anyone is interested in a word-salad you can google translate this:

https://medischonverklaardeklachten.wordpress.com/

The one that puzzles me the most is Joris van Montfrans as he seems to be an immunologist specialized in children. None of his previous publications seem to be about psychology.

https://pubmed.ncbi.nlm.nih.gov/?term=montfrans+j

Can't imagine there being 2 people with that exact name in the Netherlands tbh so it must be him. Why he'd co-sign a piece of crap like this is a mystery.

 

[Jonathan Edwards]

I get the impression that this paper is a bit like a family of stick insects that decided to go for a walk where a group of chameleons had decided to make a stake out.

 

[rvallee]

So an increase in physical activity per se does not seem sufficient to reduce fatigue. An increase in perceived activity, however, does seem important.

They really don't think much of us, uh? This is almost toddler "got your nose" level of not respecting other people's abilities. This is idiotic, no way to mince words about it.

"Of course you have to take patients seriously. Of course you want to know what they think of their treatment and how they are treated. But should you also allow them to judge scientific evidence?"

Again, this is taking people "seriously" the same way as an adult would take a toddler seriously. First of all we can judge scientific evidence to a certain degree, but none of what they do has any bit of science so that's just extra irrelevant. They have nothing, only stories and metaphors, and boy can we judge the hell out of those without even having to think much about it, they sure didn't bother.